Compared with DOACs, VKAs were associated with a lower incidence of ischemic stroke (HR 0.85; 95% CI 0.76-0.95) but a higher risk of intracranial hemorrhage (HR 1.38; 95% CI 1.17-1.62).
Cohort (n=170,404)
Yes
Do DOACs improve clinical outcomes compared to VKAs, aspirin, or no treatment in patients with non-valvular atrial fibrillation?
In a large real-world Italian cohort of NVAF patients, DOACs demonstrated a better net clinical benefit over VKAs, driven by lower rates of intracranial hemorrhage, major bleeding, and all-cause mortality.
Hazard Ratio: 0.85 (95% CI 0.76–0.95)
Absolute Event Rate: 1.62% vs 1.81%
INTRODUCTION: In a large nationwide administrative database including ∼35 % of Italian population, we analyzed the impact of oral anticoagulant treatment (OAT) in patients with a hospital diagnosis of non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: Of 170404 OAT-naïve patients (mean age 78.7 years; 49.4 % women), only 61.1 % were prescribed direct oral anticoagulants, DOACs, or vitamin-K antagonists, VKAs; 14.2 % were given aspirin (ASA), and 24.8 % no anti-thrombotic drugs (No Tx). We compared ischemic stroke (IS), IS and systemic embolism (IS/SE), intracranial hemorrhage (ICH), major bleeding (MB), major gastro-intestinal bleeding, all-cause deaths and the composite outcome, across four propensity-score matched treatment cohorts with >15400 patients each. Over 2.9±1.5 years, the incidence of IS and IS/SE was slightly less with VKAs than with DOACs (1.62 and 1.84 vs 1.81 and 1.99 events.100 person-years; HR=0.85, 95%CI=0.76-0.95 and HR=0.87, 95%CI=0.78-0.97). This difference disappeared in a sensitivity analysis which excluded those patients treated with low-dose of apixaban, edoxaban, or rivaroxaban (41.7% of DOACs cohort). Compared with DOACs, VKAs were associated with greater incidence of ICH (1.09 vs 0.81; HR=1.38, 95%CI=1.17-1.62), MB (3.78 vs 3.31; HR=1.14, 95%CI=1.02-1.28), all-cause mortality (9.66 vs 10.10; HR=1.07, 95%CI=1.02-1.11), and composite outcome (13.72 vs 13.32; HR=1.04, 95%CI=1.01-1.08). IS, IS/SE, and mortality were more frequent with ASA or No Tx than with VKAs or DOACs (p<0.001 for all comparisons). CONCLUSIONS: Beyond confirming the association with a better net clinical benefit of DOACs over VKAs, our findings substantiate the large proportion of NVAF patients still inappropriately anticoagulated, thereby reinforcing the need for educational programs.
Bo et al. (Mon,) conducted a cohort in Non-valvular atrial fibrillation (NVAF) (n=170,404). Vitamin-K antagonists (VKAs) vs. Direct oral anticoagulants (DOACs) was evaluated on Ischemic stroke (IS) (HR 0.85, 95% CI 0.76-0.95). Compared with DOACs, VKAs were associated with a lower incidence of ischemic stroke (HR 0.85; 95% CI 0.76-0.95) but a higher risk of intracranial hemorrhage (HR 1.38; 95% CI 1.17-1.62).